Study Start‑Up Project Manager – Client Dedicated

FTMAI Fortrea Development Ltd; Maidenhead; Hybrid; GBP 65,000 - 90,000; Full time

Job summary

Fortrea seeks a regulatory-focused Study Start-Up PM to lead country-level submissions, approvals and site readiness for a global client-dedicated program in London. 2-3 days onsite in hybrid model.

You will own end-to-end regulatory submissions, IRB/IEC interactions, local documentation, and alignment with HQ on timelines, budgets and local milestones, ensuring compliance and on-time delivery.

Qualifications

• 5+ years' experience in clinical research with study start-up/regulatory exposure.
• Solid knowledge of local regulatory environments and approval processes.
• Ability to work independently, manage multiple protocols, and mitigate regulatory risk.
• Strong stakeholder-management and influencing skills.
• Bachelor's degree in Life Sciences, Healthcare, Business, or related field.

Responsibilities

• Oversee end-to-end regulatory submissions and approvals per ICH-GCP, UK/local regs, and internal standards.
• Coordinate IRB/IEC and Regulatory Authority interactions, including amendments and approvals.
• Develop and oversee local regulatory documentation (ICFs, translations).
• Ensure regulatory compliance, timelines, and country commitments during start-up and close-out.
• Coordinate with CRM, CTC, CRA, Finance, and Legal to deliver submissions, CTRAs, budgets, and milestones.
• Collaborate with Headquarters to align country timelines.
• Oversee site readiness, local vendors, and country processes.
• Manage clinical and ancillary supplies, import/export, archiving, retention, and insurance processes.
• Maintain country data in clinical and finance systems.
• Act as regulatory SME, support process improvements and mentoring.

Skills

Regulatory submissions

Study start-up

Regulatory knowledge

Independent work

Stakeholder management

Education

Bachelor's degree in Life Sciences, Healthcare, Business, or related field

Job description

London | 2-3 days onsite (hybrid)

Are you a regulatory-focused Study Start-Up expert who thrives on ownership and compliance? We're looking for a Study Start-Up PM to lead country-level submissions, approvals and site readiness for a global, client-dedicated program.

What you'll own

• Oversight of end-to-end regulatory submissions and approvals in line with ICH-GCP, UK/local regulations, and internal quality standards
• IRB/IEC and Regulatory Authority interactions, including amendments and approvals
• Development and oversight of local regulatory documentation (ICFs, translations)
• Accountability for regulatory compliance, timelines, and country commitments during start-up and close-out
• Coordination with CRM, CTC, CRA, Finance, and Legal to deliver submissions, budgets, CTRAs, and local milestones
• Close collaboration with Headquarters to align country timelines
• Oversight of site readiness, local vendors, and country-level processes
• Management of clinical and ancillary supplies, import/export, archiving, retention, and insurance processes
• Maintenance of country data in clinical and finance systems
• Acting as a regulatory SME, supporting process improvement, best-practice sharing, and mentoring

What we're looking for

• 5+ years' experience in clinical research with strong study start-up/regulatory exposure
• Solid knowledge of local regulatory environments and approval processes
• Ability to work independently, manage multiple protocols, and mitigate regulatory risk
• Strong stakeholder-management and influencing skills
• Bachelor's degree in Life Sciences, Healthcare, Business, or related field

Why this role?

• High-impact regulatory leadership at the most critical study phase
• Client-dedicated model with real ownership and visibility
• Hybrid working model with 2-3 days per week in London

At Fortrea, we're all about turning the "impossible" into "I'm possible." Together, we break barriers to deliver exceptional service to our patients, fueled by a shared commitment to teamwork and excellence. Regardless of your role, we're all family, working together to achieve extraordinary results. At Fortrea, your career isn't just a job - it's a journey of making the exceptional possible, every day.